To assess the safety and tolerability of bortezomib, dexamethasone and rituximab in patients with untreated Waldenstroms macroglobulinemia. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the response rate along with attainment of stable disease and time to disease progression following treatment with this patient population. [ Time Frame: TBD ] [ Designated as safety issue: No ]

Estimated Enrollment:

30

Study Start Date:

October 2005

Study Completion Date:

February 2009

Primary Completion Date:

March 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Drug: Bortezomib

Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles

Drug: Dexamethasone

Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles

Drug: Rituximab

Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles

Detailed Description:

This is an open-label study which means both the patient and the doctor will know what drugs and doses the patient is receiving throughout the study.

Patients will receive 8 cycles of study treatment with bortezomib, dexamethasone and rituximab. Each cycle is 21 days long. Therapy is given on the first, fourth, eighth and eleventh day of each cycle, followed by a 10 day rest period. The first 4 cycles will be given one after the other. Three months after completing the fourth cycle of therapy, patients will receive one cycle of therapy every three months for a total of four more cycles.

On the first, fourth, eighth and eleventh day of each cycle, the patient will receive bortezomib and dexamethasone as an intravenous injection through a needle in your vein. On the eleventh day only, the patient will also receive rituximab as an intravenous infusion after getting bortezomib and dexamethasone.

Prior to each infusion of rituximab therapy, the patient will be asked to take some medications to prevent or reduce side effects of rituximab. These medications are benadryl, tylenol, and possibly more steroids. The doctor will determine which of these drugs are appropriate for the individual patient.

During the rituximab infusion, the patients blood pressure and pulse will be monitored frequently and the infusion rate may be decreased depending upon the side effects experienced.

After therapy is completed, the patient will be followed every three months for 2 more years for office visits and laboratory tests to determine how well they are doing and if the therapy continues to benefit them.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Clinicopathological diagnosis of Waldenstrom's macroglobulinemia (WM)

No previous therapy for WM

Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of greater than or equal to 2 times the upper limit of each institution's normal value

CD20 positive disease based on any previous bone marrow immuno-histochemistry or flow cytometric analysis performed up to 3 months prior to enrollment

Karnofsky performance status > 60

Life expectancy > 3 months

AST (SGOT) < 3 x ULN

ALT (SGPT) < 3 x ULN

Total bilirubin < 2 x ULN

Calculated or measured creatinine clearance > 30mL/minute

Serum sodium > 130 mmol/L

Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control

Male subject agrees to use an acceptable method for contraception for the duration of the study

Serious medical or psychiatric illness likely to interfere with participation in this clinical study

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250926